The U.S. Food and Drug Administration (FDA) has granted full approval to afamitresgene autoleucel, commercially known as Tecelra and also referred to as afami-cel, for the treatment of synovial sarcoma. The agency has also expanded the therapy’s indication to include patients aged 12 years and older.
Afami-cel is an engineered T-cell receptor therapy designed to recognize the cancer-associated protein MAGE-A4. The treatment represents an important option for patients with a rare and aggressive soft tissue sarcoma who have limited therapeutic alternatives after their disease stops responding to standard treatments.
The full approval follows the therapy’s accelerated approval in August 2024, when afami-cel became the first engineered T-cell therapy approved by the FDA for a solid tumor. At that time, its use was limited to adults.
“This treatment offers a meaningful new option for people with this rare cancer,” said Sandra D’Angelo, MD, a sarcoma specialist and immunotherapy expert at Memorial Sloan Kettering Cancer Center. “It is also an important step forward in the development of T cell therapies for solid tumors, which has been a major challenge.”
A Rare Cancer With Limited Treatment Options
Synovial sarcoma is diagnosed in fewer than 1,000 people in the United States each year. Although it can develop in different parts of the body, it commonly arises in the extremities or within soft tissues of the abdomen or lung.
The disease most frequently affects young adults and is slightly more common among men than women.
Treatment becomes particularly difficult after synovial sarcoma spreads to distant organs. At this stage, existing therapies may provide limited disease control, emphasizing the need for treatments that work through new biological mechanisms.
“Sarcoma in general, and synovial sarcoma in particular, is a type of cancer where more treatments are desperately needed,” Dr. D’Angelo explained. “Once the disease spreads to other parts of the body, it is very difficult to control with the therapies we have now.”
Turning a Patient’s T Cells Into a Targeted Treatment
Afami-cel is manufactured using a patient’s own immune cells. T cells are collected from the blood and genetically engineered in a laboratory before being returned to the patient through an intravenous infusion.
The modified cells are designed to circulate through the body, identify tumor cells carrying the targeted marker and initiate an immune response against the cancer.
Because these engineered cells can remain active after administration, cell therapies are sometimes described as “living drugs.”
Afami-cel belongs to a category known as T-cell receptor therapy. Although it is related to chimeric antigen receptor T-cell therapy, the two approaches recognize cancer in different ways.
CAR T cells identify markers located on the external surface of cancer cells. TCR therapies can recognize fragments of proteins that originate inside tumor cells and are presented on the cell surface by human leukocyte antigen molecules.
“With both CAR T and TCR therapies, you are giving the immune cells the ability to fight the cancer,” Dr. D’Angelo said.
The primary target of afami-cel is MAGE-A4, a protein expressed by certain tumors, including some synovial sarcomas.
Updated Trial Results Show Durable Tumor Responses
At the 2026 American Society of Clinical Oncology Annual Meeting, Dr. D’Angelo presented updated findings from the phase 2 clinical trial that supported the approval of afami-cel.
The analysis included 153 patients treated through May 2025. Participants had synovial sarcoma or myxoid/round cell liposarcoma and had previously received other treatments without achieving adequate disease control.
Following a single infusion of afami-cel, 44% of patients experienced tumor shrinkage.
Some participants achieved complete tumor disappearance and remained without disease recurrence for several years.
Patients who responded to treatment had an average survival exceeding three years, an important outcome in a population with aggressive disease and few remaining treatment options. Some patients were still alive five years after receiving the therapy.
“These findings are significant for a group of patients who have largely exhausted other treatment options,” Dr. D’Angelo said.
Engineered Cells Remained Detectable for Years
The updated findings also showed that afami-cel could persist in the body long after the initial infusion.
Many patients continued to have detectable evidence of the engineered T cells in their blood more than three years after treatment. This long-term persistence supports the potential for sustained immune surveillance following a single administration.
The preliminary results from the clinical trial were previously published in The Lancet in April 2024.
Managing the Safety Profile of Afami-Cel
Before receiving afami-cel, patients underwent chemotherapy to reduce existing immune cells and prepare the body for the engineered T-cell infusion.
Low blood cell counts were the most frequent adverse effect associated with this preparatory chemotherapy.
More than 73% of patients experienced cytokine release syndrome, a commonly observed inflammatory reaction following cellular therapies. Cytokine release syndrome occurs when activated immune cells release large quantities of inflammatory signals into the bloodstream.
For most patients treated with afami-cel, the syndrome was not severe.
Careful monitoring remains an important component of treatment, particularly during the period immediately following the infusion.
Extending TCR Therapy Beyond Synovial Sarcoma
The approval of afami-cel represents a significant development in efforts to bring engineered cell therapies into solid tumor treatment.
Dr. D’Angelo hopes that afami-cel may eventually be used against other solid tumors that carry the MAGE-A4 target. The therapy and other TCR-based approaches are also being evaluated in pediatric sarcomas.
Further investigation will determine whether this strategy can be extended to additional tumor types and whether engineered T-cell therapies can overcome some of the biological barriers that have historically limited cellular therapy in solid cancers.
The afami-cel clinical trials were funded by Adaptimmune and USWM CT, LLC.
Written by Nare Hovhannisyan, MD
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